Kornimate/medical-research-clean huggingface dataset:
first in human study on synthetic surfactant chf 5633 in respiratory distress syndrome

Conditions: Respiratory Distress Syndrome in Premature Infants

Summary: the aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of chf 5633 in preterm neonates with rds in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (bpd) and mortality.

the study will be a multicentre, open-label, single escalating dose, per-cohort design.

Eligibility criteria:
inclusion criteria: * written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures * inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6 * clinical and radiological findings typical of rds * age on admission to the study \< 24 hours from birth * requirement of endotracheal intubation for surfactant administration * fraction of inspired oxygen (fio2) \> 0.35 to maintain spo2 between 90-95 % * documentation of normal cranial ultrasound scan exclusion criteria: * use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide) * known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc) * maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy * clinical chorioamnionitis (appendix iii) * strong suspicion of congenital pneumonia/infection, sepsis * evidence of severe birth asphyxia or a 5 minutes apgar score less / equal 3 * presence of air leaks prior to study entry * neonatal seizures prior to study entry * mothers with prolonged rupture of the membranes (\> 3 weeks duration) * any condition that, in the opinion of the investigator, would place the neonate at undue risk * participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol

Keywords: respiratory distress syndrome complications of prematurity
effect of resistance exercises on liver enzymes post burn.

Conditions: Burns

Summary: resistance training will be performed for 8 weeks with thrice-weekly sessions on non-consecutive days. the program will consist of seven exercises: triceps press, biceps curl, lat pull-down, calf raise, leg press, leg extension and sit-ups using dumbbells and sandbags. each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching followed by a resistance exercise that will be done as a circuit, ending with a 5-minute cooldown. the 1 repetition maximum (1rm) is measured at baseline and following the intervention. initially, participants will do two circuits using 50% of their 1rm and repeat them 10 times for the first and second weeks, progressing to two circuits, using 60% of their 1rm and repeating 10 times for the third and fourth weeks. in the fifth and sixth weeks, participants will do three circuits using 60% of their 1rm and repeat 10 times. in the last two weeks, patients will do three circuits using 70% of their 1rm and repeat 10 times. a 90-second rest will be allowed between sets of exercises (hallsworth et al., 2011).

sixty patients who have partial thickness burn with burned body surface area (bbsa) about 30% to 50% will participate in this study after their release from intensive care unit. their ages will be ranged from 20 to 45 years. the participants will be selected from orabi hospital and randomly distributed into two equal groups. 1. group a (study group): this group includes 30 burned patients who will receive resistance exercises 8 weeks (3times/week) by using dumbbells and sand bags in addition to their physical therapy program (splinting, stretching ex. and rom ex.) and medical treatment. 1. group b (control group): this group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and rom ex.) and medical treatment.

Eligibility criteria:
inclusion criteria: * the subject selection will be according to the following criteria: * age range between 20-45 years. * male and female patients will participate in the study. * all patients have burn with bbsa about 30% to 50%. * all patients enrolled to the study will have their informed consent. exclusion criteria: * the potential participants will be excluded if they meet one of the following criteria: * cardiac diseases. * burn of sole of foot. * exposed hand or foot tendons. * lower limb amputation. * history of liver diseases. * body mass index (bmi=kg/cm2)\<30%.
the effect of laparoscopic splenectomy and azygoportal disconnection on liver reserve function for cirrhosis patients

Conditions: Cirrhosis, Liver; Splenectomy; Status; Portal Hypertension

Summary: in this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. to determine whether surgical treatment can help enhance postoperative liver reserve function and improve patient prognosis.

the patients were enrolled according to the research criteria, and collected the general basic information of the patients. after the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy and azygoportal disconnection, and the same nursing team performed the nursing after the operation. then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. during the treatment, the liver reserve function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including tbil, dbil, alb, alt, inr, pt, child-pugh, ascites, prealbumin, icg-k, icg-r 15 and icg-t/2.

Eligibility criteria:
inclusion criteria: * a clinical, radiological or histologic diagnosis of cirrhosis of any etiology * splenomegaly with secondary hypersplenism * gastroesophageal variceal bleeding * informed consent to participate in the study exclusion criteria: * hepatocellular carcinoma or any other malignancy, * child-pugh grade c * recent peptic ulcer disease * history of hemorrhagic stroke * pregnancy. * uncontrolled hypertension * human immunodeficiency virus (hiv) infection

Keywords: cirrhosis splenectomy azygoportal disconnection laparoscopy liver reserve function
the effectiveness of using bougie or cooled nasogastric tube to facilitate nasotracheal intubation

Conditions: Intubation Complication

Summary: either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx and advanced into the trachea

in oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. however, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages. in addition, the advancement of the tube from oropharynx into trachea may assist by either using magic forceps or cuff inflation technique. the aim of the study is to investigate either use a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx, and advanced into the trachea. patients were randomized into three groups by using either bougie or nasogastric tube to facilitate nasotracheal tube sliding through into trachea from assigned nostril and compared with the control group with a conventional technique. hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea were recorded. the incidence of using magill forceps to accurately place tube tip into trachea, intubation related side effects and complications were recorded at postoperative time stages.

Eligibility criteria:
inclusion criteria: * age:20-65 years * undergoing oro-maxillofacial surgery * opening mouth \> 3 cm * denied any systemic disease. * american society of anesthesiologists (asa) class:i-iii exclusion criteria: * difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance \< 6cm) * previous head and neck surgery history * upper abnormal airway diagnosed * easily epistaxis * both sides nasal cavities obstruction

Keywords: bougie, nasotracheal tube endotracheal tube intubation general anesthesia (etga)
long-term study of multi-target therapy as maintenance treatment for lupus nephritis

Conditions: Lupus Nephritis

Summary: an multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus ctx- aza therapy.

azathioprine (aza) has been used for maintenance therapy of lupus nephritis for many years. we compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs ctx-aza.

Eligibility criteria:
inclusion criteria: 1. patients who signed written informed consent form 2. sle patient, aged between 18-65 years, female or male; 3. patients diagnosed lupus nephritis according to isn/rps 2003 classification criteria, class ⅲ, ⅳ,ⅳ+ⅴ, ⅲ+ⅴ or ⅴ ln by renal biopsy 4. all patients had received induction therapy for 6 months with multi-therapy (fk506 + mmf) or intravenous ctx pulses. 5. patients were recruited when received partial remission or complete remission after 6 months induction therapy. complete remission: proteinuria \ 35 g/l, elevated scr \ 30 g/l, elevated scr \<0.3mg/dl,no extra-renal complications. exclusion criteria: 1. patients who didn't sign written informed consent form or could not obey the protocol. 2. patients who didn't received the cr or pr criterion. 3. patients who have impaired liver function, with alt/gpt or ast/got twice more than the normal upper limit or who have active hepatitis. 4. wbc \<3000/mm3 in peripheral blood . 5. patients with central nervous system symptoms. -
fempulse therapy first-in-human experience

Conditions: Urinary Bladder, Overactive

Summary: the purpose of this clinical trial is to investigate a new medical device treatment for overactive bladder (oab) in women.

the fempulse system is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function. it is believed that stimulation of these nerves may help relieve the symptoms of oab.

Eligibility criteria:
inclusion criteria: * females ≥21 yrs with overactive bladder exclusion criteria: * is or was recently pregnant * has a metal pelvic implant or any electrically active implanted medical device * has a urinary tract or vaginal infection * had a previous hysterectomy, pelvic radiation or pelvic cancer * has significant pelvic organ prolapse * had bladder treatment with onabotulinumtoxina in the previous 12 months or tibial nerve stimulation within the previous 30 days * has a significant heart condition or a history of vasovagal reaction or low blood pressure

Keywords: overactive bladder women neuromodulation bioelectronic medicine non-significant risk
treatment protocol of child saa with the injection of mesenchymal stem cells（umbilical cord derived）

Conditions: Complications of Organ Transplant Stem Cells Umbilical Cord

Summary: mesenchymal stem cells (msc) is a non hematopoietic stem cells (hsc) in adult bone marrow and takes part in the bone marrow microenvironment. the response rate of early treatment on children's saa application combined with anti-thymocyte globulin (atg) (40-50 days after atg treatment) is associated with long-term effect. the injection of umbilical cord derived mesenchymal stem cells combined with atg improves the efficacy of children with saa.

1. mesenchymal stem cells were prepared by in vitro separation, screening, and culture from healthy human umbilical cord tissue; the " injection of mesenchymal stem cells (umbilical) manufacturing and verification regulation " was also formulated. 2. the starting dose of umbilical cord derived msc was 0.5-1.0 \* 106 cells /kg, based on the previous human studies; and the maximum tolerated dose was 1 \* 107 cells /kg 3. the response and complete remission rate, relapse rate of the injection of umbilical cord derived mesenchymal stem cells (or combined with atg ) for child with saa were determined.

Eligibility criteria:
inclusion criteria: * non-severe aplastic anemia (nsaa)atients exclusion criteria: * severe aplastic anemia (saa) patients

Keywords: mesenchymal stem cells (msc) umbilical cord thymocyte globulin (atg) severe aplastic anemia (saa)
target engagement and response to oxytocin

Conditions: Schizophrenia

Summary: this study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

the study will determine whether oxytocin (ot) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (scst) program, and it will test a possible mediator of this effect. subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: ot with scst; placebo with scst; ot with training control condition; placebo with training control condition. target engagement will be measured in an ot challenge (placebo versus ot one week apart) prior to baseline assessment. the measure of target engagement will be eeg mu suppression while observing biological motion. a social cognition battery will be administered at baseline, at midpoint after 6 weeks of scst, and at completion of training at 12 weeks. the battery will include measures of social cue identification and mentalizing.

Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder * stable on an antipsychotic medication exclusion criteria: * positive pregnancy test history of head injury

Keywords: social cognition oxytocin
link of interest and training model

Conditions: Peritoneal Carcinomatosis

Summary: * the surgical device used to perform pipac procedure is commercialized by a single manufacturer under a monopoly regimen, and a formal training (economically supported by the manufacturer) is mandatory for surgeons who want to buy the device.relations with the company and solutions to extend training require specific analysis from an ethical point of view. * based on the growing number of published papers from a growing number of international centers, the controlled training model is not limiting, and it is a successful model of development of this breakthrough innovation. * but with the major involvement of the industry and the control of training, the different levels of interest could induce ethical questions.

* objective: using the example of pressurized intra peritoneal aerosol chemotherapy (pipac), the investigators analyze the development model of this procedure and provide an ethical analysis of the involvement of the industry in this development. * summary background data: in the case of breakthrough innovation, medical training is essential for safe use of the new procedure. pharmaceutical companies may organize this training; but when it becomes the only training opportunity to use the device, scientists and clinicians are exposed to a conflict of interest. * methods: the investigators performed a literature review of pipac publications using the strobe criteria. then, the investigators conducted interviews with an expert panel to analyze the ethical impact of involvement of the industry in the development of the pipac procedure.

Eligibility criteria:
inclusion criteria: * expert in pipac * more than 30 pipac per year exclusion criteria: -
metformin for the prevention of oral cancer in patients with oral premalignant lesions

Conditions: Erythroplakia; Leukoplakia; Oral Cavity Carcinoma; Proliferative Verrucous Leukoplakia

Summary: this phase i trial tests whether metformin works in reducing the annual transformation (development of invasive cancer) of oral precancerous lesions into cancerous lesions. metformin is a drug approved for the treatment of diabetes, but studies have shown that it may have some anticancer properties. giving metformin may help prevent or slow the development of oral cancer from precancerous lesions.

primary objective: i. to evaluate the transformation-free-survival in lesion types erythroplakia (ep) and verrucous hyperplasia (vh). 'transformation' is defined as the development of invasive cancer. secondary objective: i. to evaluate the current spontaneous regression rates, i.e., percentages of patients having lesion disappear within 1-year post treatment, in all four lesion types and compare them with historical documented regression rate in literature. exploratory objective: i. to evaluate the transformation-free-survival in lesion types homogenous leukoplakia (hl) and non-homogenous leukoplakia (nhl). outline: patients receive metformin orally (po) once daily (qd) on days 1-3 and then po twice daily (bid) for up to 12 months in the absence of unacceptable toxicity. after completion of study treatment, patients are followed up every 3 months for 24 months.

Eligibility criteria:
inclusion criteria: * age 18-85 * clinical appearance of lesion * homogenous leukoplakia * non- homogenous leukoplakia * erythroplakia * proliferative verrucous leukoplakia * histologic appearance * no dysplasia * mild dysplasia * moderate dysplasia * severe dysplasia * diabetics: if on metformin, will get them to 2000 mg per day, if not, will add metformin in consultation with endocrinologist * all subjects must be able to comprehend and sign a written informed consent document * willing and able to be available for the duration of the study * in general good health with no contraindication to biopsy or metformin therapy * laboratory results exclusion criteria: * carcinoma in-situ, verrucous carcinoma, invasive squamous cell carcinoma (scca) * exclude systemic causes of the lesion: pemphigus, pemphigoid, systemic lupus erythematosus (sle), lichenoid drug reaction, human immunodeficiency virus (hiv), syphilis * exclude local inciting factors: rule out (r/o) but allowing 2 weeks to pass and see if there is resolution, if not and doesn't resolve with local measures, medical treatment, enroll * frictional: sharp tooth * trauma * immunosuppression by natural illness or medically induced * hypersensitivity or allergic reaction to metformin or some other contraindication
active and healthy brotherhood: a program for chronic disease self-management for black men

Conditions: Chronic Disease; Obesity; Hypertension; Diabetes; Self Care; Medication Adherence

Summary: this study will test ways to improve health behaviors using an intervention that has been specially designed for african-american men. the program, called active \& healthy brotherhood (ahb), will provide information on basic health, and healthy eating, physical activity, stress management, and how to get medical care when needed.the ahb intervention will be compared to a control group that will receive basic health information in videos and brochures.


Eligibility criteria:
inclusion criteria: 1. aa (based on self-report) 2. self-reported male 3. aged at least 21 years 4. non-institutionalized (i.e., community-dwelling, not living in assisted living facilities, nursing homes, etc.) 5. at high risk for developing chronic disease (e.g., not meeting current guidelines for pa and/or f\&v intake; current smoker; diagnosed with high cholesterol) or 6. currently diagnosed with diabetes, hypertension, or cardiovascular disease 7. residents of forsyth county, nc (or surrounding areas and able to attend group sessions in forsyth county). exclusion criteria: 1. have had a cardiovascular procedure (e.g., heart surgery), heart attack, heart failure, stroke in the last 6 months 2. have cognitive, visual, auditory, physical functional (e.g., unable to walk unassisted), or language impairment precluding participation in group discussion, learning activities, or data collection. 3. currently achieve \>150 min/wk of moderate intensity pa or \>75 min/wk of vigorous intensity pa and currently consume \> 9 servings of f\&v daily. 4. are currently enrolled in a chronic disease management program. 5. are unwilling to accept randomization assignment or planning to move from local area in \<2 years. 6. are currently receiving chemotherapy/radiation treatments. participants will be required to obtain approval from a health care provider prior to participation in the study if they: 1. are unable to participate in moderate pa due to physical limitations as indicated by positive (risk) responses on the pa readiness questionnaire (par-q) and/or physician disapproval on the par medical examination. 2. have bp\>180/\>110 and/or hba1c\>12 and/or triglycerides \>500. 3. have health conditions that could preclude changes to diet (e.g., irritable bowel syndrome, celiac disease)
new biomarkers in the prediction of chemotherapy-induced cardiotoxicity.

Conditions: Cardiotoxicity; Chemotherapy Effect; Chemotherapy Induced Systolic Dysfunction

Summary: early detection and thus rapid therapy of cardiotoxicity related to chemotherapy are essential for restoring cardiovascular function. the complete recovery of the cardiovascular system decreases with time to identify the presence of cardiotoxic damage. the project aims to define new biomarkers for the early detection of cardiotoxicity in patients treated with chemotherapy.

the most effective approach to minimizing the consequences of cardiotoxicity of oncological treatment is its early identification, adjustment of oncological treatment (change of procedure, dose, drugs), and immediate initiation of cardiovascular therapy. however, the current standard for monitoring the cardiovascular system in cancer patients identifies cardiotoxicity only if functional impairment has already occurred, which precludes any chance of effective prevention. the aim of the project is to identify new biomarkers for the early detection of the cardiotoxic effect of chemotherapy in women with breast cancer.

Eligibility criteria:
inclusion criteria: * breast cancer * chemotherapy with a known cardiotoxic side effect exclusion criteria: * known cardiovascular disease